{"id":"aad50dce-fe2c-4ff8-b34d-1bfb1b5faf54","slug":"fda-cmr-versius-denovo-2024","filingNumber":"DEN230078","filingType":"fda_de_novo","jurisdiction":"us_fda","applicantCompanyId":"6bbb447e-0278-4ae1-822d-8b546420511e","filingDate":"2023-11-21T12:00:00.000Z","decisionDate":"2024-10-11T12:00:00.000Z","status":"granted","clearanceScope":"FDA De Novo authorization for the CMR Surgical Versius system (initial US indication); reported 2024.","sources":[{"url":"https://cmrsurgical.com","title":"Versius FDA De Novo (reported 2024)","sourceName":"CMR Surgical (official)"}],"verificationPosture":"reported","capFlagNotes":"Filing number not yet captured; De Novo pathway reported. Upgrade to verified when the DEN-number is confirmed.","relatedIncidentId":null,"reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-04T23:17:19.455Z","updatedAt":"2026-06-05T15:35:51.061Z","applicantCompany":{"id":"6bbb447e-0278-4ae1-822d-8b546420511e","slug":"cmr-surgical","name":"CMR Surgical"},"modelLinks":[{"id":"5e7584eb-97d5-4eae-ac32-e90400fa0588","modelId":"34aec096-0484-4591-b8c1-f65bd183344f","regulatoryFilingId":"aad50dce-fe2c-4ff8-b34d-1bfb1b5faf54","createdAt":"2026-06-04T23:17:19.614Z","model":{"slug":"cmr-versius","modelName":"Versius"}}]}